Control of components, containers and closures – methods and specs
Facility and Equipment requirements
Vendor selection & management
Manufacturing & Records during phase 1 studies with an eye toward later development
Specific requirements for various types of products: biologics, combinations, sterile products
Process Validation to conduct for phase 1 clinical supply process
Preparing relevant SOPs for early stage development
Multi-product facilities considerations
Providing relevant information in the IND application
Who should Attend
Manager
Directors
Lead workers in Regulatory Affairs Quality Assurance and Quality Control
Supervisors
Workers who will review GMP documents for early phase products
Workers who will prepare GMP documents for early phase products
Past Events
FDA`s GMP Expectations for Phase IV and First-in-Man Clinical Trials 2020 - 2020, (34511)
FDA`s GMP Expectations for Phase III and First-in-Man Clinical Trials 2019 - 07-08 Nov 2019, Boston, Massachusetts, United States (34510)
FDA`s GMP Expectations for Phase II and First-in-Man Clinical Trials 2018 - 06-07 Dec 2018, Tampa Marriott Westshore, Florida, United States (34509)
FDA`s GMP Expectations for Phase I and First-in-Man Clinical Trials 2017 - 31 Aug - 01 Sep, 2017, Zurich, Switzerland (69883)
FDA`s GMP Expectations for Phase I and First-in-Man Clinical Trials 2017 - 10-11 Aug 2017, DoubleTree by Hilton Hotel San Francisco Airport, Burlingame, California, United States (67248)
FDA`s GMP Expectations for Phase I and First-in-Man Clinical Trials 2016 - 18-19 Aug 2016, Philadelphia, Pennsylvania, United States (31146)
FDA`s GMP Expectations for Phase I and First-in-Man Clinical Trials 2016 - 13-14 Jul 2016, Chicago, Illinois, United States (59976)
Important
Please, check "FDA`s GMP Expectations for Phase IV and -in-Man Clinical Trials" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Medical device, Medical laboratories, Pharma
